510(k) K991001

MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER by Ep Medsystems — Product Code DRF

K991001 is an FDA 510(k) premarket notification submitted by Ep Medsystems for the device "MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER". The FDA issued a decision of Substantially Equivalent on July 15, 1999. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Ep Medsystems has at least 10 other 510(k) clearances on record.